Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 30830158.
- Also identified by DOI 10.1001/jamainternmed.2018.7040 and PMC identifier 6503639.
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Abstract
This cohort study of FDA- and drug sponsor–written communications evaluates the communication of nonefficacy benefits of new drugs approved on the basis of noninferiority trials alone.
Medical subject headings
- Communication
- Drug Approval
- Drug Industry
- Equivalence Trials as Topic
- United States Food and Drug Administration